BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT

    MDR report key: 2951077 · Received February 8, 2013

    Report

    Report Number
    2955842-2013-00448
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 18, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING EVALUATION CONFIRMED THE ALLEGED ISSUE OF A BROKEN WIRE. THE INSTRUMENT WAS FOUND TO HAVE A FRAYED GRIP CABLE AT THE DISTAL IDLER PULLEY. FRAYED STRANDS WERE OBSERVED TO BE STICKING OUT AT THE INSTRUMENT'S WRIST. OTHER CABLES AT WRIST WERE REPORTEDLY NOT DAMAGED. ENGINEERING EVALUATION ALSO FOUND THE SAME FRAYED GRIP CABLE TO BE DERAILED. THE GRIP CABLE WAS DERAILED AT THE DISTAL IDLER PULLEY. THE GRIPS WERE STILL ABLE TO OPEN AND CLOSE. ENGINEERING CONCLUDED THAT THE CABLE DERAILMENT WAS LIKELY DUE TO THE CABLE LOSING CONTACT WITH PULLEY DURING WRIST ARTICULATION. ENGINEERING ALSO CONCLUDED THAT THE FLEET ANGLE BETWEEN THE PROXIMAL AND DISTAL PULLEYS MIGHT HAVE CONTRIBUTED TO THE DERAILMENT. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI INGUINAL HERNIA REPAIR PROCEDURE, THE SURGICAL STAFF ALLEGED THAT A BROKEN WIRE WAS OBSERVED WITH THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT . THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THERE WAS NO ALLEGATION OF ANY HARM, INJURY, OR ADVERSE OUTCOME TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53981 MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10120809 964

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SURGICAL SYSTEM AND ACCESSORIES